THOUGHT LEADERSHIP

Basic research in the 1990’s showed that antibodies aimed at a cell surface marker called cytotoxic T-lymphocyte antigen 4 (CTLA-4) stimulated an immune response that resulted in the killing of the tumor cells. Another cell marker, programmed death-1 (PD-1), was found to have the ability to prevent the immune system from killing cancer cells. These discoveries led to the development of cancer therapy using inhibition of negative immune regulation.

We knew that immunotherapy finally had a breakthrough when James Allison and Tasuku Honjo received the Nobel Prize in Physiology or Medicine in 2018 for “discovery of cancer therapy by inhibition of negative immune regulation.”

I was in New York City on March 1, 2020 when the news reported that the first positive case of COVID-19 had been identified in that state. A pharmaceutical company seeking accelerated approval for one of their products had selected PROMETRIKA to re-monitor their study’s efficacy data after a recommendation from the European Medicines Agency. I ended up traveling to NYC on short notice after learning about an urgent need for a monitoring visit at one of the oldest and largest teaching hospitals in the United States. While leading a two-day monitoring visit at that hospital, it was announced that a coronavirus patient had been admitted to their emergency room for the first time. The research staff in my vicinity were anxious about this invisible, contagious, mystery virus, and it had just been confirmed that their colleagues were interacting with a patient that had been exposed to it. I walked back to the hotel that night and didn’t think anything of it when the song, “The Only Living Boy in New York” came up at random on my playlist.

So, your organization has made the decision to transition to a new eTMF system. Congratulations on taking this step! Depending on your organization and your role, you may or may not have been part of the decision-making process for choosing the system. You may be somewhat familiar with the system or encountering it for the first time. Either way, now that the ink on the contract is dry, it is time to begin making the most of your new eTMF.

Buzzwords like “analytics” and “visualization” have been used in the clinical trial space since the ability to collect massive quantities of clinical trial data became a reality. Everyone wants the instant gratification of real-time trend detection, and software developers have responded in kind by providing a dizzying array of analytics options. How do you make an informed decision about which option is the right fit?